FDA Product Code NXO: Calprotectin, Fecal
The Device Is Used For The Measurement, In Human Stool, Of Fecal Calprotectin, A Neutrophilic Protein That Is A Marker Of Mucosal Inflammation. The Device Can Be Used As An Aid In The Diagnosis Of Inflammatory Bowel Disease (ibd), Crohn's Disease And Ulcerative Colitis And To Differentiate Ibd From Irritable Bowel Syndrome.
Leading manufacturers include DiaSorin, Inc. and B?hlmann Laboratories AG.
FDA 510(k) Cleared Calprotectin, Fecal Devices (Product Code NXO)
About Product Code NXO - Regulatory Context
510(k) Submission Activity
15 total 510(k) submissions under product code NXO since 2006, with 14 receiving FDA clearance (average review time: 157 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
NXO devices are reviewed by the Immunology panel. Browse all Immunology devices →